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news.Plethora Solutions Holdings, a developer of products for the treatment and management of urological disorders, has announced that its European Phase III double-blind placebo controlled study of PSD502 for the treatment of premature ejaculation has met its three co-primary endpoints of intravaginal ejaculation latency time and index of premature ejaculation for ejaculatory control and sexual satisfaction domains.
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The European study is one of two pivotal Phase III studies running in parallel with identical protocols. The second Phase III study is being conducted in North America and is expected to complete in the first half of 2009. Once the results from the US Phase III study become available, data from the two studies will be combined for submission for regulatory approval in the US and Europe, the company said.
Each Phase III study is a multi-center, randomized, double blind, placebo-controlled efficacy study and the program is expected to recruit a total of 540 patients across the two studies. Patients are treated for a 12-week period with an optional open label phase of up to nine months.
The European study was conducted with 300 randomized patients across 32 investigational centers in four countries across Europe. Of these, 265 patients also entered the optional nine month open label study.
Initial analyses show that PSD502 produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints. The intravaginal ejaculation latency time (IELT) geometric mean for PSD502 was four minutes compared to one minute in placebo (p<0.0001). There was a seven point difference between PSD502 and placebo in the IPE domain for Ejaculatory Control (p<0.0001) and a six point difference between PSD502 and placebo in the index of premature ejaculation (IPE) domain for sexual satisfaction (p<0.0001), where a two point difference in a 16 point range is considered clinically significant. PSD502 was well tolerated and there were no systemic adverse events, the company said. Mike Wyllie, CSO of Plethora, said: "We are clearly delighted with these highly significant results from the European Phase III clinical study and now await the final results from the US study in the first half of 2009. We already have a partner for the US market and will now move ahead with our discussions with prospective partners across other territories."